Experts at NIH meeting say H5N1 research moratorium may end soon

Dec 18, 2012 (CIDRAP News) – As a meeting to discuss issues related to federally funded H5N1 avian influenza research wrapped up today, experts anticipated that a voluntary moratorium on work with lab-modified strains that have increased transmissibility might end soon and said they sensed agreement about lab biosecurity levels.

The National Institutes of Health (NIH) held the 2-day meeting to gather feedback from flu researchers, others in the science community, and the public on its draft framework for funding H5N1 gain-of-function studies and to continue an international dialogue on issues related to benefits and risks of the research.

Today's sessions focused on biosafety issues and summed up the main points of yesterday's discussion on the framework and other issues.

Lab biosafety is one of the issues that have stalled the lifting of the moratorium, which has been in place for nearly a year. In October the Department of Health and Human Services (HHS) issued a Federal Register notice asking whether H5N1 should be designated as an HHS special agent and if it should be a "Tier 1" select agent, a new category for agents that would require additional precautions, such as greater physical security and screening for staff.

The request for comments follows a determination by a federal interagency committee that H5N1 viruses may pose a severe threat to human health and safety. The finding came from the Centers for Disease Control and Prevention's (CDC's) Intragovernmental Select Agents and Toxins Technical Advisory Committee (ISATTAC).

Comments on H5N1 as a Tier 1 select agent were due yesterday; however, Robbin Weyant, PhD, who directs the select agents and toxins division of the CDC's Coordinating Office for Terrorism Preparedness and Emergency Response, said at the meeting today that the agency has extended the comment period through January 2013.

At a press conference today at the close of the NIH meeting, Anthony Fauci, MD, director of the of the NIH's National Institute of Allergy and Infectious Diseases (NIAID), said that H5N1 researchers whom the agency funds have been holding to the moratorium until the NIH has a final draft of its new funding policy in place. These include the two groups that published studies this year that raised concerns about an accidental or intentional release of lab-modified H5N1 strains,.

He said the agency is trying to expedite the process for the H5N1 research projects it funds, including the two high-profile groups that published studies on lab-modified H5N1 strains transmissible in mammals: a team led by Yoshihiro Kawaoka, DVM, PhD, from the University of Wisconsin at Madison and one led by Ron Fouchier, PhD, from Erasmus University in the Netherlands.

Officials from the US Department of Health and Human Services used the 2-day meeting to gather feedback on the draft funding policy and is urging interested parties to submit written comments on it though Jan 10, 2013.

Fauci said the researchers who signed the voluntary research moratorium last January have informally signaled that they are waiting for the NIH to release its funding framework, even though it doesn't apply to them, before they end the moratorium.

Amy Patterson, MD, told reporters that the robust discussions at the forum better equip federal officials with the perspectives needed to refine the framework. "We're looking forward to rolling up our sleeves to rethink parts of the framework," she said. "We'll be reaching out to the US Department of Agriculture (USDA) and other departments to make sure there are no unexpected impacts on their funding."

She said that on the basis of the policy and feedback so far, a key feature that would trigger another level of review for funding would be respiratory droplet transmission in mammals.

Fauci added that federal officials didn't expect air-tight consensus on many issues, but he called the meeting and the discussions an important credibility step in the policy-setting process. He and Patterson said they hoped the biosafety and funding framework issues will be finalized at the same time, which would pave the way for research teams to resume their work.

Much of today's NIH discussion on biosafety revolved around how to communicate the risks to the public and if any safety enhancements are needed.

Joseph Kanabrocki, PhD, CBSP, assistant dean for biosafety and associate professor of microbiology at the University of Chicago, said he supported the expansion of local institutional biosafety committees (IBCs). He added that improving the education of scientists and students about lab biosafety would go a long way toward engaging the public on the issues.

He and other presenters suggested that codes of conduct for lab researchers would also be a useful way to build more accountability into the safety system.

There was little support at the meeting for limiting H5N1 gain-of-function studies to biosafety-level 4 (BSL-4) labs, which have the highest security measures. Many experts maintained the work can safety been done in enhanced BSL-3 conditions and that limiting the work to the few BSL-4 labs across the globe would slow the pace of H5N1 studies.

David Harper, CBE, a special adviser to the World Health Organization's (WHO's) assistant director-general for health, security, and environment, told the group today that the WHO will host a meeting at the end of February on broader dual-use research issues.

Fouchier told CIDRAP News that moratorium signees from the Eastern Hemisphere are ready to lift the moratorium, but he said they are waiting to see what will happen with the US framework discussions. He said he didn't hear any new arguments at the meeting and that there seems to be fairly good agreement on the BSL level for gain-of-function H5N1 studies. Fouchier added that he was hopeful that the moratorium would end soon.

Kawaoka told CIDRAP News that the meeting provided a good hearing on all the different opinions on the research issues, which he said was the meeting's goal.